Enroute Transcarotid Stent System

Approval order statement

APPROVAL FOR THE ENROUTE TRANSCAROTID STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) FOR THE TREATMENT OF PATIENTS AT HIGH RISKFOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW.1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; 2) PATIENTS MUST HAVE A VESSEL DIAMETER OF 4-9MM AT THE TARGET LESION; AND 3) CAROTID BIFURCATION IS LOCATED AT MINIMUM 5 CM ABOVE THE CLAVICLE TO ALLOW FOR PLACEMENT OF THE ENROUTE TRANSCAROTID NPS.